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Efficacy and tolerability of 0.2% brimonidine tartrate for the treatment of acute non-arteritic anterior ischemic optic neuropathy (NAION): a 3-month, double-masked, randomised, placebo-controlled trial

  • Clinical Investigation
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Abstract

Introduction

Neuroprotection may be an option in ischemic optic nerve disease. There have been promising reports about the neuroprotective ability of topical brimonidine in animal studies. Therefore, we tested whether 0.2% brimonidine tartrate could improve the outcome of patients with non-arteritic anterior ischemic optic neuropathy (NAION). The study was stopped after an interim analysis, having not proven its feasibility within practicable time frame.

Methods

A 3-month, double-masked, placebo-controlled, randomised European multicenter trial conducted according to good clinical practice rules. Thirty-six patients (22 m, 14 f), older than 40 years with first eye involvement and typical signs of NAION were included in the study within the 1st week after visual loss (VA 0.05–1.0) and were randomized to treatment with either brimonidine 0.2% (Alphagan) or placebo. Visual acuity (VA, primary endpoint), visual field (VF, Humphrey 30–2 and Goldmann, quantified by a modified Esterman grid) and automated swinging flashlight test (SWIFT) were performed at baseline, 2 weeks, 4 weeks and 12 weeks after first visit. Primary analysis aimed at intention-to-treat group (ITT, n=29), secondary analysis to the per protocol population (PP, n=25). Tolerability and safety were tested in the safety group (n=36). A two-sample two-sided t-test was used for statistical analysis (alpha level at 0.05).

Results

VA did not show statistically significant difference by treatment. There were non-significant trends for better visual field results in the brimonidine group. Adverse events consisting of local irritation were observed six times in the verum and three times in the placebo group. No serious adverse events occurred.

Conclusion

In contradiction to an open-labeled, retrospective study published by Fazzone et al., the results of this trial did not indicate any harmful effect of brimonidine in patients suffering from NAION. However, a statistically significant advantage for the patients receiving brimonidine tartrate could not be shown.

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Notes

  1. Positive differences mean a better result of the verum group in comparison with the placebo group.

  2. Negative differences mean a better result of the verum group in comparison with the placebo group.

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Acknowledgements

We thank Ulrich Schiefer and Jens Pätzold for their great support with the automated analysis of the Goldmann visual fields and Birgit Meyer for friendly and thorough assistance. We thank Peter Schieber for his longstanding help with all study matters. The following members of the BRAION study group contributed by providing and caring for study patients: Daphne Gamer, Tübingen, Steffi Knappe and Hans-Peter Vick, Rostock, Rüdiger Schmid, Peter Charbel Issa and Wolfgang Schrader, Würzburg, Frank Wilhelm and Dirk Ehrich, Halle, Klaus Rüther, Matthias Scherer and Bert Müller, Berlin, Claudia Kuhli and Alina Zubcov, Frankfurt, Stefan Wiese and Wolf Lagrèze, Freiburg, Jörn Kuchenbecker, Magdeburg, Irene Gottlob, Leicester (UK) Christine Langerhorst, Amsterdam (NL).

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Authors and Affiliations

  1. Steinbeis Transfer Centre for Biomedical Optics and Function Testing Tübingen, Schleichstr. 12–16, 72076, Tübingen, Germany

    Barbara Wilhelm & Holger Lüdtke

  2. Department Pathophysiology of Vision and Neuro-Ophthalmology, University Eye Hospital Tübingen, Tübingen, Germany

    Helmut Wilhelm

Authors
  1. Barbara Wilhelm
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  2. Holger Lüdtke
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  3. Helmut Wilhelm
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The BRAION study group

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Correspondence to Barbara Wilhelm.

Additional information

This study was investigator-initiated and in part supported by Allergan with an unrestricted research grant.

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The BRAION study group., Wilhelm, B., Lüdtke, H. et al. Efficacy and tolerability of 0.2% brimonidine tartrate for the treatment of acute non-arteritic anterior ischemic optic neuropathy (NAION): a 3-month, double-masked, randomised, placebo-controlled trial. Graefe's Arch Clin Exp Ophthalmo 244, 551–558 (2006). https://doi.org/10.1007/s00417-005-0102-8

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  • DOI: https://doi.org/10.1007/s00417-005-0102-8

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